A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- change in quality of life
Study Overview
Brief Summary
The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age>18 years
- •History of stage I-III breast cancer
- •Patient scheduled to receive or within 2 weeks of receiving intravenous chemotherapy for their breast cancers
- •Eastern Cooperative Oncology Group Performance status of <3
- •Ability to understand English
Exclusion Criteria
- •Planning to start yoga on their own within the next 12 weeks
- •Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
- •Severe chronic obstructive pulmonary disease
- •Class III or IV heart failure
- •Child C cirrhosis
- •End-Stage renal disease
- •Exclusion Criteria:
- •Planning to start yoga on their own within the next 12 weeks
- •Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study
- •Severe chronic obstructive pulmonary disease
- •Class III or IV heart failure
- •Child C cirrhosis
- •End-Stage renal disease
Arms & Interventions
start yoga classes immediately
12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence concurrently with the start of chemotherapy.
Intervention: Yoga (Other)
Start yoga classes after 3 months
12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence 3 months after start of chemotherapy
Intervention: Yoga (Other)
Outcomes
Primary Outcomes
change in quality of life
Time Frame: 12 weeks
to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga immediately and those start yoga 3 months later.
Secondary Outcomes
No secondary outcomes reported
Investigators
Theresa Shao
Assistant Professor
Icahn School of Medicine at Mount Sinai